Metapex Plus

Resin, Root Canal Filling

Meta Biomed Co., Ltd.

The following data is part of a premarket notification filed by Meta Biomed Co., Ltd. with the FDA for Metapex Plus.

Pre-market Notification Details

Device IDK202617
510k NumberK202617
Device Name:Metapex Plus
ClassificationResin, Root Canal Filling
Applicant Meta Biomed Co., Ltd. 270, Osongsaengmyeong 1-ro, Osong-eup, Heungdeok-gu Cheongju-si,  KR 28161
ContactSuk Song Oh
CorrespondentApril Lee
Withus Group Inc 106 Superior Irvine,  CA  92620
Product CodeKIF  
CFR Regulation Number872.3820 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-09
Decision Date2021-04-14


Device IdentifiersubmissionNumberSupplement
08806387894827 K202617 000
08806387894803 K202617 000
08806387894797 K202617 000

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